Important Safety Information

ABSTRAL® (fentanyl) sublingual tablets CII
ABSTRAL® (AB-stral) sublingual tablets are used to manage breakthrough pain in adults with cancer (18 years of age and older) who are already routinely taking other opioid pain medicines around-the-clock for cancer pain.
IMPORTANT:
Do not use ABSTRAL unless you are regularly using another opioid pain medicine around-the-clock for your cancer pain and your body is used to these medicines (this means that you are opioid tolerant). Keep ABSTRAL in a safe place and away from children or anyone for whom it has not been prescribed.

Get emergency medical help right away if:
  • a child takes ABSTRAL. ABSTRAL can cause an overdose and death in any child who takes it.
  • an adult who has not been prescribed ABSTRAL takes it
  • an adult who is not already taking opioids around-the-clock, takes ABSTRAL

These are medical emergencies that can cause death. If possible, try to remove ABSTRAL from the mouth.
Read the Medication Guide that comes with ABSTRAL completely before you start taking ASBTRAL, and each time you get a new prescription. There may be new information. The Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment. Be sure to share this important information with members of your household and other caregivers.

Abstral can cause life-threatening breathing problems that can lead to death:
  • Don’t take ABSTRAL if you are not opioid tolerant, meaning you must be already taking another opioid (narcotic) around-the-clock for your cancer pain.
  • If you stop taking your around-the-clock opioid pain medicine for your cancer, you must stop taking Abstral, as you may no longer be opioid tolerant.
  • Take ABSTRAL only as prescribed by your healthcare provider. You must not take more than 2 doses of ABSTRAL for each episode of breakthrough cancer pain.
  • You must wait 2 hours before treating a new episode of breakthrough cancer pain with ABSTRAL.
  • Don’t switch from ABSTRAL to any other fentanyl containing product without talking with your healthcare provider, as it may result in fatal overdose.
  • Only use ABSTRAL for the purpose it was prescribed. Never give it to anyone else, even if they have the same symptoms. It may harm them or cause death.
ABSTRAL is a prescription narcotic medicine that contains fentanyl. It is intended to be used only to treat pain in cancer patients (18 years of age and older) who are already routinely taking other opioid pain medicines around-the-clock for cancer pain. It should be prescribed only by healthcare professionals who are knowledgeable of, and skilled in the use of, Schedule II opioids to treat cancer pain.

Don’t take ABSTRAL:
  • If you are not opioid tolerant.
  • If you are allergic to any of the ingredients in ABSTRAL
  • For short-term pain that you would expect to go away in a few days, such as pain after surgery, headache, migraine, or dental pain.
ABSTRAL is only available through a program called the TIRF REMS Access program. To receive ABSTRAL, you must talk to your healthcare provider, understand the benefits and risks of ABSTRAL, agree to all of the instructions, and sign the Patient-Prescriber Agreement form.

Before taking ABSTRAL tell your healthcare provider if you:
  • Have trouble breathing or have lung problems such as asthma, wheezing, or shortness of breath.
  • Have or had a head injury, seizures, or brain problems.
  • Have a slow heart rate, low blood pressure, or other heart problems.
  • Have metal health problems, including major depression, schizophrenia, or hallucinations.
  • Have a past or present drinking or drug abuse problem, or a family history.
  • Are or plan to become pregnant or breastfeed, as ABSTRAL may cause serious harm to your unborn or nursing baby.
  • Are taking any prescription, non-prescription, vitamins, or herbal supplements before you begin to take ABSTRAL.
How to take ABSTRAL
  • Take ABSTRAL exactly as prescribed. Don’t take more or more often than prescribed.
  • Place the tablet under your tongue and let it dissolve completely. Do not suck, chew or swallow the tablet.
  • Take a dose for an episode of breakthrough cancer pain. If not better within 30 minutes, take 1 more dose. You may not take more than 2 doses per episode.
  • Wait at least 2 hours after the last dose of the previous episode before treating a new episode of breakthrough cancer pain.
  • It is important to continue to take your around-the-clock pain medication.
  • Be very careful taking other medicines that may make you sleepy, such as anti-depressants, sleeping pills, antihistamines, or tranquilizers.
  • Do not drink alcohol while taking ABSTRAL. Do not drive, operate heavy machinery, or do dangerous activities until you know how ABSTRAL affects you. ABSTRAL can make you sleepy. Ask your healthcare provider when it is ok to do these activities.
Possible side effects of ABSTRAL are:
  • Abstral can cause life-threatening breathing problems that can lead to death.
  • Decreased blood pressure, which can make you feel dizzy or lightheaded if you get up too fast from sitting or lying down.
  • Potential for addiction, abuse, and physical dependence. Do not stop taking ABSTRAL or any opioid without talking to your healthcare provider.
  • Most common side effects are nausea, sleepiness, and headache.
  • Constipation is a very common side effect of pain medicines (opioids) including ABSTRAL, and unlikely to go away without treatment.
You or a family member should call your healthcare provider or get emergency medical help right away if you:
    • Have trouble breathing, as this can be life-threatening
    • Have drowsiness with slowed breathing
    • Have shallow breathing (little chest movement with breathing)
    • Feel faint, very dizzy, confused, or have other unusual symptoms
These symptoms can be a sign that you have taken too much ABSTRAL or the dose is too high for you. These symptoms may lead to serious problems or death if not treated right away. If you have any of these symptoms, do not take any more ABSTRAL until you have talked to your healthcare provider.

Abstral® is a federally controlled substance (CII) available by prescription only. This information is not intended to replace discussions with your doctor.
Please see Full Prescribing Information, with Boxed Warning